Marijuana Approach Bias Retraining and Neural Response in Youth

NCT ID: NCT02723149

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-10-31

Brief Summary

This study aims to determine if a marijuana (MJ) Approach Avoidance Task (AAT) intervention reduces cannabis use compared to a control condition containing no active components of AAT. Adolescent heavy MJ users (N=40, ages 16-21) will be randomly assigned to MJ-AAT (n=20) or control condition (MJ-Sham, n=20) for three weeks. The MJ-AAT includes six sessions designed to reduce action tendencies to approach marijuana. The MJ-Sham includes six MJ-AAT-sham conditions. Substance use and cognitive assessment will identify changes in MJ use patterns and mechanisms of treatment outcomes. Additionally, using an functional magnetic resonance imaging marijuana cue reactivity task, we will determine differences in neural response in reward regions before and after 3 weeks of either AAT or sham treatment.

Conditions

Alcohol Approach/Avoidance Task; Sham Approach/Avoidance Task

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Approach Avoidance Training Condition

The AAT group will push away the joystick from marijuana pictures 90% of the trials and pull towards the marijuana pictures 10% of the trials.

Group Type: EXPERIMENTAL

Marijuana Approach Avoidance Training

Intervention Type: BEHAVIORAL

Approach Avoidance Training (AAT) is a novel computerized procedure that modifies implicit approach tendencies by training individuals to selectively avoid drug- related stimuli, thereby overriding habitual approach tendencies. Participants are randomized to either the treatment or sham condition. Treatment duration involves 6 training sessions of approximately 15 minutes each (400 trials). AAT requires minimal training and involves only a computer and a joystick, in which participants are either pulling or pushing the joystick when different marijuana or non-marijuana images are displayed with either yellow (pull) or blue (push) border.

Sham Condition

The sham group will undergo the same procedures, except the ratio for marijuana pictures will be 50% push and 50% pull.

Group Type: SHAM_COMPARATOR

Marijuana Approach Avoidance Training

Intervention Type: BEHAVIORAL

Approach Avoidance Training (AAT) is a novel computerized procedure that modifies implicit approach tendencies by training individuals to selectively avoid drug- related stimuli, thereby overriding habitual approach tendencies. Participants are randomized to either the treatment or sham condition. Treatment duration involves 6 training sessions of approximately 15 minutes each (400 trials). AAT requires minimal training and involves only a computer and a joystick, in which participants are either pulling or pushing the joystick when different marijuana or non-marijuana images are displayed with either yellow (pull) or blue (push) border.

Interventions

Marijuana Approach Avoidance Training

Approach Avoidance Training (AAT) is a novel computerized procedure that modifies implicit approach tendencies by training individuals to selectively avoid drug- related stimuli, thereby overriding habitual approach tendencies. Participants are randomized to either the treatment or sham condition. Treatment duration involves 6 training sessions of approximately 15 minutes each (400 trials). AAT requires minimal training and involves only a computer and a joystick, in which participants are either pulling or pushing the joystick when different marijuana or non-marijuana images are displayed with either yellow (pull) or blue (push) border.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• between age 16 and 21
• having >50 lifetime marijuana use episodes and a pattern of at least weekly marijuana use for the past year (>1+/week for 52 weeks) at study entry.

Exclusion Criteria

• not having a parent to consent (for those under age 18)
• prenatal alcohol (>2 drinks on an occasion or >4 drinks in a week) or any tobacco or illicit drug exposure
• premature birth (<34 weeks gestation), birth weight <5 lbs, or other gestational or perinatal complications
• history of a serious medical or neurological problems that could affect blood oxygen level dependent (BOLD) response, brain development, or study participation, including diabetes and recurrent migraine
• current severe Diagnostic and Statistical Manual of Mental Disorders (DSM-5) major Axis I psychiatric disorder (i.e., exclude participants with bipolar disorder, psychotic disorder)
• use of any illicit substance (e.g., cocaine, methamphetamines) other than alcohol or marijuana > 100 times
• history of major neurological disorder or head trauma (with loss of consciousness >10 minutes)
• history of learning disability, pervasive developmental disorder, or other condition requiring special education
• current use of medications that affect cerebral blood flow
• non-correctable visual or hearing problems
• non-fluent in English
• MRI contraindications (e.g., braces, claustrophobia, irremovable metal implants or piercings)
• pregnant on day of scan
• intake of psychoactive medication as tested by urine drug screen.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lindsay M Squeglia, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

44583

Identifier Type: -

Identifier Source: org_study_id